Infants with necrotizing enterocolitis (NEC) are born at a distinct disadvantage: the inability to absorb nutrients naturally due to a necrotic bowel. Though the causes remain unknown, the methods for treating it are inconsistent, timely, and expensive both for families and hospitals [See 1]. Current standards of care include antibiotic treatment and removal of the necrotic portions of the bowel. If surgical treatment is necessary, ostomies are created and infants are put on intravenous nutrition until their bowel has healed and reanastomosis can occur [See 2]. However, intravenous nutrition has significant debilitating long-term effects that lengthen and complicate the healing process [See 3]. Surgical NEC occurs in a population of 3,500 patients annually in the United States.
Overview
By designing various embodiments of the present invention ostomy refeeding system that connects the two ostomies, the infant can resume enteral feeding, as opposed to expensive intravenous nutrition [See 4]. By using an aspect of an embodiment of the present invention device, hospitals can save, for example, at least $2,400 per patient for providing nutritional support alone.
Currently, no devices or universal protocols exist that allow clinical staff to cleanly insert bowel contents for refeeding. An aspect of an embodiment of the present invention refeeding system (whereby one or more embodiments or portions of an embodiment may be referred to as an “OstoPump”) is that, among other things, creates a temporary artificial bowel that is external from the body and connects the two ostomies, expanding on the current standard of care. Some advantages of this are that such an external device of the various embodiments of the present invention shall have less rigorous biocompatibility constraints and that they are able to utilize existing technologies for managing ostomy wound care.
An aspect of an embodiment of the present invention solution (method and system) is that, among other things, it will not only provide the tools needed to prevent leakage and backflow, but will also include a validated protocol for implementing the solution into the Neonatal Intensive Care Unit (NICU) workflow.
An aspect of an embodiment of the present invention solution is that, among other things, it will help to create a uniform approach to refeeding so that it may be practiced successfully in multiple health centers. By implementing an aspect of an embodiment of the present invention solution, patients can resume enteral feeding, heal more quickly, and be discharged sooner, reducing costs for both the hospitals and families [See 4, 5].
The Food and Drug Administration (FDA) provides alternative paths for devices—that may be applicable to an embodiment of the present invention device—targeting underserved populations. The patient population of infants with NEC is about 1 to 3 of every 1,000 live births. However, only 30% of NEC patients require surgical intervention, so the patient population that an embodiment of the present invention solution (device and method) would be serving is approximately 3,500 patients annually [See 6]. Because the annual patient population is under 4,000, the present inventors can file for a Humanitarian Device Exemption (HDE) to classify various embodiments of the present invention (e.g., a model or type of OstoPump) as a Humanitarian Use Device (HUD) [See 7].
An aspect of an embodiment of the present invention may be provided to hospitals and NICUs. Moreover, if an embodiment of the present invention is provided to consumers, for example, it may include the device and means to train consumer on its use with the new protocol. Various embodiments of the present invention (e.g., a model or type of OstoPump) may be sold as one solution per patient that will include sufficient materials to refeed for the recovery period.
An aspect of an embodiment of the present invention provides, but not limited thereto, an anchoring cone device (and related method) that may include a funnel or the like embedded in the cone. The bottom may be hollow to allow space for the stoma and/or ostomy and collect any backflow of bowel contents. Flanges are used to adhere the device to the skin. The flange may serve as a retention member.
An aspect of an embodiment of the present invention provides, but not limited thereto, a temporary artificial intestine that may include a single multilumen balloon catheter that connects the two ostomies to allow for autonomous flow of bowel contents. Anchoring cones or the like (other shaped covers) are used over each ostomy and/or stoma to, among other things, stabilize the system.
Necrotizing Enterocolitis
Current standard of care for infants with surgical NEC relies on intravenous nutrition [See 1]. There is currently no solution to recycle contents from a proximal ostomy to a distal ostomy, so potentially viable bowel contents are drained and discarded. In addition to being costly, other complications with total parenteral nutrition (TPN) include liver disease and anticoagulant disorders [See 3]. Physicians often order refeeding during the recovery period, but methods vary depending on clinical staff. When ordered to refeed, nurses do not have the designated tools, training, or methods. Additionally, the present inventors have determined that the most common method of refeeding is inserting a syringe or a catheter into the distal ostomy; however the present inventors submit that it is not successful because there is no way to anchor it into the anatomy. This lack of protocol and dedicated tools often leads to failure and clinicians that then resort to 100% intravenous nutrition as opposed to successfully refeeding.
An aspect of an embodiment of the present invention provides, but not limited thereto, a device for refeeding bowel content of a subject. The device may comprise: a proximal member configured to cover a proximal ostomy of a subject; a distal member configured to cover a distal ostomy of a subject; a bowel lumen member having a proximal end and a distal end. The proximal end of the bowel lumen is disposed at (or adjacent or proximal to) the proximal member and the distal end of the bowel lumen is disposed at (or adjacent or proximal to) the distal member. The bowel member is configured to carry bowel contents between the proximal ostomy and the distal ostomy. The device may further comprises: a proximal balloon configured to be disposed in the bowel respective to the proximal ostomy; a distal balloon configured to be disposed in the bowel respective to the distal ostomy; a proximal inflation lumen configured to inflate the proximal balloon so as to engage and contact a circumferential areal of a proximal bowel; and a distal inflation lumen configured to inflate the distal balloon so as to engage and contact a circumferential areal of a distal bowel.
An aspect of an embodiment of the present invention provides, but not limited thereto, a method for refeeding bowel content of a subject. The method may comprise: covering a proximal ostomy of a subject; covering a distal ostomy of a subject; disposing a bowel lumen member between the proximal ostomy and distal ostomy, wherein the bowel member is configured to carry bowel contents between the proximal ostomy and the distal ostomy. The method may comprises disposing a proximal balloon in the bowel of the subject respective to the proximal ostomy; disposing a distal balloon in the bowel of the subject respective to the distal ostomy; inflating the proximal balloon so as to engage and contact a circumferential areal of a proximal bowel; and inflating the distal balloon so as to engage and contact a circumferential areal of a distal bowel.
An aspect of an embodiment of the present invention provides, but not limited thereto, a device for refeeding bowel content of a subject. The device may comprises: a proximal member configured to cover a proximal ostomy of a subject; a distal member configured to cover a distal ostomy of a subject; and a bowel lumen member having a proximal end and a distal end. The proximal end of the bowel lumen is disposed at (or adjacent or proximal to) the proximal member and the distal end of the bowel lumen is disposed at (or proximal or adjacent to) the distal member, and wherein the bowel member is configured to carry bowel contents between the proximal ostomy and the distal ostomy.
An aspect of an embodiment of the present invention provides, but not limited thereto, a method for refeeding bowel content of a subject. The method may comprise: covering a proximal ostomy of a subject; covering a distal ostomy of a subject; and disposing a bowel lumen member between the proximal ostomy and distal ostomy, wherein the bowel member is configured to carry bowel contents between the proximal ostomy and the distal ostomy.
An aspect of an embodiment of the present invention provides, but not limited thereto, a device for refeeding bowel content of a subject configured to cover a proximal ostomy (or cover at least in part and/or anchor to the proximal ostomy) of a subject and/or a distal member configured to cover a distal ostomy (or cover at least in part and/or anchor to the distal ostomy) of the subject. The device may include a bowel lumen member configured to carry bowel contents between the proximal ostomy and the distal ostomy (or to other location, equipment or destination; or between other locations, sets of equipment, and destinations). An aspect of an embodiment of the present invention provides, but not limited thereto, a method for refeeding bowel content of a subject by disposing a bowel lumen member between a proximal ostomy and distal ostomy, wherein the bowel member is configured to carry bowel contents between the proximal ostomy and the distal ostomy (or to other location, equipment or destination; or between other locations, sets of equipment, and destinations).
These and other objects, along with advantages and features of various aspects of embodiments of the invention disclosed herein, will be made more apparent from the description, drawings and claims that follow.